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FDA 510(k)

PARAMAX TOTAL PROTEIN REAGENT TP

K-Number: K845052 · 1984-04-13

ApplicantAmerican Dade
Decision Date1984-04-13
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PARAMAX TOTAL PROTEIN REAGENT TP is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1984-04-13 under 510(k) number K845052. The device is classified under product code CEK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARAMAX TOTAL PROTEIN REAGENT TP?

PARAMAX TOTAL PROTEIN REAGENT TP is a medical device that received FDA 510(k) clearance on 1984-04-13. The listed applicant is American Dade. The 510(k) number is K845052.

When did PARAMAX TOTAL PROTEIN REAGENT TP receive FDA 510(k) clearance?

PARAMAX TOTAL PROTEIN REAGENT TP received FDA 510(k) clearance on 1984-04-13, under 510(k) number K845052.

Who is the listed applicant for PARAMAX TOTAL PROTEIN REAGENT TP?

The FDA 510(k) record lists American Dade as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARAMAX TOTAL PROTEIN REAGENT TP?

The FDA product code for PARAMAX TOTAL PROTEIN REAGENT TP is CEK.

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Other records listing American Dade as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

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Related Devices (Code: CEK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K992846HICHEM TOTAL PROTEIN REAGENTElan Holdings, Inc.K973108TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50Diagnostic Chemicals , Ltd.K980042CARESIDE TOTAL PROTEINExigent Diagnostics, Inc.K971524TOTAL PROTEIN OR TPCarolina Liquid Chemistries Corp.K961864CSF/URINE TOTAL PROTEINTeco DiagnosticsK955905STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAYSolarcare Technologies Corp,Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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